Study on Nivolumab for Multiple Myeloma Patients After Idecabtagene Vicleucel Treatment
Sponsor: Wake Forest University Health Sciences
ClinicalTrials ID:NCT06523621
This clinical trial is exploring whether the drug nivolumab can improve treatment outcomes for patients with relapsed refractory multiple myeloma who have not had an ideal response to a previous treatment called idecabtagene vicleucel.
Patient Parameters
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Program Overview
The purpose of this study is to see if adding the drug nivolumab can help improve the response in patients with relapsed refractory multiple myeloma (RRMM) who did not respond optimally to a previous treatment called idecabtagene vicleucel. The study will look at how well patients respond after receiving nivolumab every four weeks for two cycles.
Description
This study involves patients with relapsed refractory multiple myeloma (RRMM) who have already tried at least two other treatments and did not respond well to them. These treatments include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Patients who did not have a strong response to idecabtagene vicleucel will receive nivolumab to see if it can improve their condition. The study will monitor the overall response after two cycles of nivolumab, given every four weeks. Researchers will also check for changes in the behavior of CAR-T cells and any additional side effects compared to past data.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate.
- Be 18 years or older.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have measurable disease according to specific criteria within 28 days before receiving idecabtagene vicleucel.
- Have previously received idecabtagene vicleucel and shown a partial response or better.
- Enroll in the study between 3 to 6 weeks after receiving idecabtagene vicleucel.
- Have recovered from previous treatment side effects to a certain level.
- Show adequate organ function based on lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and for five months after treatment.
- Be able to understand and follow study procedures.
Exclusion Criteria
- Have certain other medical conditions like Waldenstrom macroglobulinemia, POEMS syndrome, or amyloidosis.
- Have active infections or uncontrolled HIV or hepatitis B.
- Be pregnant or breastfeeding.
- Have active cytokine release syndrome or neurotoxicity.
- Have had another cancer within the last two years, except for certain skin or cervical cancers.
- Have received other anti-myeloma treatments within 30 days before starting nivolumab.
- Have uncontrolled health issues like heart failure or psychiatric conditions.
- Have had a stem cell or organ transplant.
- Have active autoimmune diseases, except for certain conditions like controlled diabetes or hypothyroidism.
- Have a history of lung disease or cannot take certain preventive medications.
- Require high doses of steroids or other immunosuppressive drugs.
- Be a prisoner or involuntarily incarcerated.
- Have a history of heart inflammation or allergies to study drugs.
- Have had serious side effects from nivolumab or ipilimumab in the past.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center | 27103 | Winston-Salem | North Carolina |
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